MAUDE Adverse Event Report: ARTHREX, INC. BUR,RND,SJ,8 FLUT 3.0MMX 7CM; BURR,SURGICAL

Model Number	BUR,RND,SJ,8 FLUT 3.0MMX 7CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during an ankle arthroscopy the tip broke inside the patient.All fragments were retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint allegation was confirmed.One unpackaged ar-7300rbe batch 15049234 was received for evaluation.Upon visual inspection, the outer tube appeared to be bent.Further evaluation revealed that the inner tube was broken; only half of it remained attached to the hub.Functional testing could not be conducted because the inner tube was broken.The most likely cause(s) of the reported failure is user error, such as prying/leveraging the device or using it without irrigation.Dfu-0215-eor0.2_fmt_en.F.Precautions.6.Do not allow the rotating portion of any device to touch any metallic object, such as a cannula or arthroscope, during use.Damage to both devices is likely.Damage to the device can range from a slight distortion or dulling of the blade/burr edge to actual fracture of the tip in vivo.If such contact does occur, inspect the tip.If there are cracks, fractures or dulling, or if there is any other reason to suspect a blade is damaged, replace it immediately.7.Excessive "side-loading" on the device during use does not improve cutting performance and in extreme cases will cause irreversible damage to the device.

• Brand Name: BUR,RND,SJ,8 FLUT 3.0MMX 7CM
• Common Device Name: BURR,SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19831202
• Report Number: 1220246-2024-06923
• Device Sequence Number: 18170546
• Product Code: GFF
• UDI-Device Identifier: 00888867041967
• UDI-Public: 00888867041967
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BUR,RND,SJ,8 FLUT 3.0MMX 7CM
• Device Catalogue Number: AR-7300RBE
• Device Lot Number: 15049234
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown